Effectiveness and safety of dolutegravir/lamivudine/abacavir versus bictegravir/emtricitabine/tenofovir alafenamide as first-line regimens in real-world settings (MICTLAN study)

Abstract

Background

Integrase strand transfer inhibitor (INSTI)-based regimens, such as dolutegravir/lamivudine/abacavir (DTG/3TC/ABC) and bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), are recommended as first-line antiretroviral therapy (ART) for people living with HIV (PLH). This study compares their efficacy and safety in ART-naïve men living with HIV (MLH) in a real-world setting over 48 weeks.

Methods

This open-label, randomized clinical trial (February 2021–October 2024) at Hospital de Infectología “La Raza” enrolled ART-naïve MLH with HIV-1 RNA ≥500 copies/mL and creatinine clearance >30 mL/min. Participants were randomized 1:1 to BIC/FTC/TAF or DTG/3TC/ABC. The primary endpoint was undetectable viral load (<50 copies/mL) at week 48, with safety assessed by adverse events (AEs) per DAIDS criteria.

Results

Of 311 participants, 153 received BIC/FTC/TAF and 158 DTG/3TC/ABC. Virologic suppression was achieved in 90% of the BIC/FTC/TAF group and 86% of the DTG/3TCC/ABC group (p = 0.32). Median CD4+ counts were 649 cells/µL (BIC/FTC/TAF) and 723 cells/µL (DTG/3 TC/ABC) (p = 0.18). DTG/3TC/ABC had higher gastrointestinal AEs (21.5% vs 14.3%; p = 0.04) and grade 3 neuropsychiatric AEs. BIC/FTC/TAF showed higher insomnia rates. Abacavir-related hypersensitivity occurred in 0.6%.

Conclusion

Both regimens showed high efficacy. BIC/FTC/TAF was more effective in patients with low baseline CD4 + counts, while DTG/3TC/ABC performed better with higher viral loads. DTG/3TC/ABC had more neuropsychiatric AEs and rare hypersensitivity reactions.